Atlas FDA

ITG

37 FDA 510(k) clearances · Product code

35 daysmedian time to decision
92 days90th percentile
37clearances measured

FDA profile

Official device name
Bandage, Cast
Device class
Class I (low risk)
Regulation
21 CFR 890.3025
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2002: 1 · 2004: 7 · 2007: 2 · 2008: 4 · 2009: 4 · 2018: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CONFORMA(TM) PLASTER BANDAGES (K873111)The Kendal Co.1987-10-09
DEKNA BAND KIT (K862115)Deknatel, Inc.1986-08-19
T.P.G. CAST TAPE (K842573)The Poly Group, Inc.1984-08-10
HEXCELITE (K840416)Hexcel Medical1984-03-23
NON WETTING UNDERCAST PADDING (K833732)American Medical Disposable, Inc.1983-12-12
SOFFBAN ORTHOPEDIC PADDING (K832992)Smith & Nephew, Inc.1983-11-14
ORTHOPEDIC CASTING TAPE MAXCAST (K832237)Cutter Laboratories, Inc.1983-08-16
SUPPORT PRODUCTS EXAMPLE PROSET CAST (K830650)Isopedix Corp.1983-07-07
YESONA PLASTER OF PARIS BANDAGE (K831492)Watson Phillips Y Cia. Sucs., S.A. DE C.V.1983-06-30
URETHANE ORTHOPAEDIC CASTING TAPE (K820890)Hexcel Medical1982-06-23
WEBRIL CAST PADDING (K820140)Stan-Pak Ent.1982-02-12
SPECIALIST CAST PADDING (K820155)Stan-Pak Ent.1982-02-12
ULTRACAST WATERLESS SYNTHETIC RESIN CAST (K813052)Zimmer, Inc.1982-02-04
CARAFLEX ELASTIC POLYMER PLASTER BANDA (K813219)Carapace, Inc.1981-12-17
CRYSTONA (K811754)Smith & Nephew, Inc.1981-07-20
URETHANE ORTHOPAEDIC CASTING TAPE (K811164)Hexcel Medical1981-05-27
ORTHOSIS BANDAGES (K810877)Ortho-Cast, Inc.1981-04-17
CELLONA PLASTER VARNISH (K810111)Secol Co.1981-02-04
CELLONA (K802792)Secol Co.1980-12-10
CELLAMIN (K802796)Secol Co.1980-11-24
IPOCON 7 (K800749)Ipos Luneburg1980-07-28
BVN (K800695)Donald J. Mangus, M.D.1980-05-02
PRE-PADDED PLASTER/PARIS BAND/SPLINTS (K800752)Ortho-Care, Inc.1980-04-21
COTTON UNDER CAST PADDING (K800195)Winn Hirsch & Assoc.1980-02-11
PROCAST (K791831)Medical Specialties, Inc.1979-09-24
FELTLOC CAST PADDING (K791305)Howmedica Corp.1979-07-30
3M ORTHOPEDIC CASTING TAPE (K791094)3M Company1979-07-24
DELTA-LITE (K790320)Johnson & Johnson Professionals, Inc.1979-05-18
CONFORM STRETCH BANDAGE (5SIZES) (K771452)Kendall Research Center1977-09-12
BANDAGES, SPEC. X-TRA HARD OR PLASTER (K770929)Johnson & Johnson Professionals, Inc.1977-06-02
CUTTER CAST 7 (K770742)Cutter Laboratories, Inc.1977-04-28
BANDAGES, PLASTER OF PARIS & SPLINTS (K770340)Johnson & Johnson Professionals, Inc.1977-02-28
LIGHTCAST II STOCKINETTE (K770134)Solar Laboratories, Inc.1977-01-26
LIGHTCAST II CASTING SYSTEM (MODIFIED) (K770133)Solar Laboratories, Inc.1977-01-26
HEXCELITE SHEET SPLINTS (K760841)Hexcel Medical1976-11-01
TAPE, LIGHTCAST II WB (K760413)Solar Laboratories, Inc.1976-08-23
CAST MATERIAL (WICKET STOCKINETTE) (K760003)Zimmer, Inc.1976-07-26

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Every clearance here is in the API, with alerts when new ones post.